




**Job Description Summary** =========================== To develop and document Quality plans and procedures as required. Prevent and resolve Quality problems. Improve areas of high\-quality costs. Represent quality interests and concerns on project teams. Conduct root cause analysis and investigation for customer complaints and non\-conformance product. Ensure compliance with Corporate, ISO, FDA, and Local standards requirements.**Job Description** =================== **Job Responsibilities** * Provide technical support to resolve quality problems in development, pilot, manufacturing * Design and conduct quality engineering studies to determine causes of quality nonconformances, initiate changes in process, tooling, etc., to correct them. * Organize and generate detailed quality information reports to engineering, manufacturing, and management. * Provide documented instructions for performance of QC inspections, including QC plans, inspection and test procedures, and quality Standards. * Exercise control over the quality of conformance of the products generated in his area\\Design and qualify inspection and test equipment. * Lead and guide peers and direct\-reporting personnel, on how to conduct the Nonconformance process (NC). * Development of Test Methods. * Development of Control Plans. * Approve/support validations protocols (Software/IQs/OPs/PQs) if applicable. **Education** * Bachelor’s degree in technical sciences or Engineering. **Knowledge \& Skills** * Minimum 1year experience in Quality/Manufacturing or Engineering positions. * Knowledge on International Regulations and Standards (i.e., ISO\-13485, FDA, etc.). * Knowledge on Quality Tools and statistical techniques. (Control charts, sampling plans, Design of experiments, etc.). * Knowledge on Quality systems. * Communication, Reports, Data analysis. * Root cause analysis techniques. * Ability to communicate in English (Oral and written) fluently. Required Skills Optional Skills . **Primary Work Location** ========================= MEX Juarez Healthcare**Additional Locations** ======================== **Work Shift** ==============


